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This phase II trial is studying the side effects and how well giving fludarabine phosphate, busulfan, anti-thymocyte globulin followed by donor peripheral blood stem cell transplant, tacrolimus, and methotrexate works in treating patients with myeloid malignancies. Giving chemotherapy, such as fludarabine phosphate and busulfan, before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplantedcells from a donor can make an immune response against the body's normal cells. Giving anti-thymocyte globulin before transplant and tacrolimus and methotrexate after transplant may stop this from happening.

Further study details as provided by Fred Hutchinson Cancer Research Center:

Primary Outcome Measures:

Incidence of acute GvHD [ Time Frame: Day 100 post-transplant ]

Maximum grade of acute GVHD and the number of therapies required to treat GVHD will be determined.

Secondary Outcome Measures:

Pharmacokinetics of IV busulfan including interdose variability and evaluation of a limited sampling strategy [ Time Frame: At 3.25, 4.5, 6, 8, 11, and 24-hours after the beginning of infusion on days -5, -4, and -3 ]

Thymoglobulin pharmacokinetics [ Time Frame: On day -3 prior to the first dose, on day -1 one hour after completion of infusion and on day 1 at 0900 ]

Incidence of donor cell engraftment [ Time Frame: By day 100 ]

Incidence of system toxicities >= grade 3 as graded per CTCAE v.3 [ Time Frame: Up to day 100 after transplantation ]

Incidence of chronic GvHD [ Time Frame: Day 100 ]

Incidence of non-relapse mortality defined as death without history of post-transplant relapse [ Time Frame: At day 100 ]

Incidence of non-relapse mortality defined as death without history of post-transplant relapse [ Time Frame: At 1 year ]

Incidence of relapse [ Time Frame: At 1 year ]

Defined by either morphological or cytogenetic evidence of chronic myelogenous leukemia (CML), AML, MDS or other myeloproliferative disease in marrow, blood, or other sites, or laboratory evidence of residual disease.

Relapse-free survival [ Time Frame: At 1 year ]

Incidence of EBV activation defined as an increase in plasma EBV DNA to >= 1000 copies/mL as determined by quantitative polymerase chain reaction (PCR) [ Time Frame: Up to 1 year ]

Patients receive fludarabine phosphate IV over 30 minutes on days -9 to -6, busulfan IV over 3 hours on days -5 to -2, and anti-thymocyte globulin IV over 6 hours on days -3 and -2 and over 4 hours on day -1. Patients undergo allogeneic PBSC transplant on day 0. Patients then receive tacrolimus IV continuously or PO every 12 hours beginning on day -1 and taper to day 180 and methotrexate IV on days 1, 3, 6, and 11.

VI. Determine the incidence of non-relapse mortality at day +100 and at 1 year (yr).

VII. Determine the incidence of relapse.

VIII. Determine relapse-free survival.

IX. Determine the incidence of Epstein-Barr virus (EBV) activation.

OUTLINE:

Patients receive fludarabine phosphate intravenously (IV) over 30 minutes on days -9 to -6, busulfan IV over 3 hours on days -5 to -2, and anti-thymocyte globulin IV over 6 hours on days -3 and -2 and over 4 hours on day -1. Patients undergo allogeneic peripheral blood stem cell (PBSC) transplant on day 0. Patients then receive tacrolimus IV continuously or orally (PO) every 12 hours beginning on day -1 and taper to day 180 and methotrexate IV on days 1, 3, 6, and 11.

After completion of study treatment, patients are followed at 1 year.

Eligibility

Information from the National Library of Medicine

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DONOR: donor must consent to peripheral blood stem cell (PBSC) mobilization with granulocyte colony-stimulating factor (G-CSF) and leukapheresis; related donors will be collected at Fred Hutchinson Cancer Research Center (FHCRC), while unrelated donors will be collected through the National Marrow Donor Program (NMDP) or other donor centers